News

Exposed Nerve

Cyberonics has implanted its pacemaker in thousands of epileptics. It wants to expand to the depression market. Still needed: an accounting of those who died or were injured after receiving its implant.

By Craig Malisow 

Houston-based Cyberonics has made millions of dollars implanting its patented pacemaker in kids and adults with epilepsy around the globe.

This is high-tech, last-ditch, no-other-options stuff. The company's pacemaker has been shown to succeed where medication and brain surgery fail, ending years of torture for people battling their own bodies. More than 30,000 children and adults have received an implant.

But Cyberonics is a big company that wants to be a giant. Its problem is that it has a single product, and treatment-resistant epilepsy is a limited market. Cyberonics estimates its potential U.S. population at 425,000.

The real money is in mood disorders, which is why the company spent $50 million in the last seven years studying the device's efficacy on treatment-resistant depression.

Cyberonics estimates there are 4.4 million Americans living with depression that's resistant to drugs and electroshock therapy. After years of battling the Food and Drug Administration, Cyberonics in February received the agency's conditional approval to enter its pacemaker in the depression market. Its stock soared. CEO Robert "Skip" Cummins told shareholders that not only would really depressed people no longer have to kill themselves, but the company was poised to dominate the $60 billion TRD market.

Next up, according to the patents Cyberonics has already secured, would be to use the same device to treat eating disorders, Alzheimer's, obesity, migraines, endocrine disorders, congestive heart failure, comas and the catch-all "pain."

But before it can get to depression, Cyberonics has to meet certain FDA conditions. And Cyberonics has an interesting history with the FDA.

In 2001, the agency issued a warning letter to the company for failing to properly report 60 deaths its pacemaker could have caused or contributed to. The company also failed to properly report 102 patient infections. Cyberonics had withheld the data from the FDA until two months after a routine inspection.

Cyberonics resolved those issues but received another warning letter last December, which the company must rectify for full approval.

Cyberonics is optimistic the FDA will give it the key to the depression market. In a press release, the company described the federal violations outlined in the warning letter as "outstanding bioresearch monitoring issues," which is the company's way of telling shareholders it must do the following:

1. Investigate and explain why thousands of patients had to be reimplanted with a second pacemaker;

2. Investigate and explain the causes of 81 deaths reported between 2001 and 2003; and

3. Investigate and explain the cause of each reported adverse effect, including instances where the device dislodged and migrated throughout the body; cases of vocal cord paralysis; and increased seizures.

Cummins is confident the company will hit the depression market by the end of May.

Sam Goldsmith is only five, but he's been to hell and back more times than anyone can count. At three months, after a course of routine immunization shots, he developed a fever that never really let go. Seizures rack his brain, knocking him to the floor. Whenever this happens, Dave and Monika Goldsmith divide duties: One holds their writhing child and the other grabs his E.T. backpack -- a pharmacy-in-a-bag -- and sets a timer.

If the seizure doesn't quit after five minutes, they shoot Sam with five milligrams of Valium. After ten minutes, they step up to Verset and call 911. If he's still seizing after 20 minutes, he's in the ICU, climbing a pharmacological ladder: Ativan. More Verset. Fosphenytoin. The highest rung is the phenobarbital coma, and it's lights out, Sam.

But then, there's also the magnet.

The magnet can stop a seizure cold. It triggers the pacemaker in Sam's chest, which zaps his vagus nerve, which leads to the brain. In medical terms, there is no explanation for the "mechanism of action," which means that no one -- not neurologists, not Cyberonics -- knows exactly why the device works. All that's understood is that vagus-nerve stimulation can reduce and even eliminate seizures in otherwise treatment-resistant epileptics.

After exhausting dozens of medications, the Goldsmiths wound up in the office of renowned neurologist Angus Wilfong. Wilfong, a medical director of the epilepsy program at Texas Children's Hospital, is an assistant professor of pediatrics and neurology at Baylor College of Medicine. Wilfong also founded a vagal-therapy program at the Children's Hospital of Wisconsin. Wilfong told the Goldsmiths about his patients' positive experiences with vagus-nerve stimulation, and he referred them to pediatric neurosurgeon John Laurent.

In 1987, Laurent co-founded Texas Children's Hospital's Brachial Plexus Program, the largest of its kind in the world. Laurent's team operated on babies who, at birth, tore or stretched the bundle of nerves between the neck and shoulders. Because of the size of their patients and the delicacy of the damaged nerves, brachial-plexus surgery is an especially difficult procedure.

The Goldsmiths researched VNS, poring over literature for a better understanding of the risks and benefits involved. The most they could find was that, because the vagus nerve is so close to the vocal cords, some patients experienced hoarseness or a tickling in their throats. They decided the minimal risk was worth offering Sam a chance at a seizure-free life. In 2002, Laurent implanted Sam's pacemaker.

With Wilfong and Laurent, the Goldsmiths placed Sam among the finest care in the country. But after about a year of continued seizures, they got a call from Wilfong's office.

We may have a problem.

X-rays showed that Laurent had inverted the wires connecting to Sam's vagus nerve, just as he had in at least 74 other children, according to a class-action lawsuit filed in Harris County District Court in 2003. (The Goldsmiths are not part of the suit.)

But the news wasn't entirely bad. According to the Goldsmiths, Wilfong said that the device was still working properly and wouldn't need to be replaced.

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